A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.

Trial Profile

A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 06 Aug 2017

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate (Primary)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics
  • Acronyms DTPA (BOOSTRIX)-049 BST: 048
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 17 Apr 2017 Planned primary completion date changed from 22 Apr 2019 to 13 May 2019.
    • 24 Jan 2017 Planned number of patients changed from 770 to 680.
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